U.S. OKs J&J drug for 2 mental disorders in children

By Lisa Richwine

WASHINGTON (Reuters) - Johnson & Johnson won U.S. approval to promote the drug Risperdal for treating schizophrenia and bipolar disorder in children and teenagers, officials said on Wednesday.

The prescription drug is the first medicine cleared specifically to treat schizophrenia in children, the Food and Drug Administration said.

Risperdal is already sold to treat adults with schizophrenia and bipolar disorder, as well as for irritability associated with autism in children ages 5 to 16.

Doctors have been using Risperdal and other antipsychotic medicines to treat schizophrenia and bipolar disorder, but the FDA stamp of approval will allow Johnson & Johnson to promote the drug for schizophrenic patients ages 13 to 17, and for short-term treatment of bipolar episodes in ages 10 to 17.

The clearance also gives doctors important information about dosing and side effects, FDA officials said.

First approved in 1993, Risperdal is one of J&J's biggest products, but is expected to face competition from cheaper generics next year.

J&J currently reaps global annual sales of more than $4 billion from Risperdal and a newer treatment called Invega that is derived from the active ingredient of Risperdal.

Schizophrenia, in which patients lose touch with reality and can have delusions or hear voices, typically begins at age 18 for men and 25 for women, according to the Merck Manual of Medical Information.

About 0.1 percent to 1 percent of schizophrenia cases are seen in the younger age group for which Risperdal was approved, FDA officials said.

Bipolar disorder, also known as manic-depressive illness, causes wide swings in mood, energy and ability to function.

J&J studies found a higher Risperdal dose was no more effective than a lower one in children. That information will be included on the drug's label, FDA officials said.

Side effects in the pediatric studies were similar to the experience in adults. The most common effects reported were drowsiness, fatigue, increase in appetite, anxiety, nausea, dizziness, dry mouth, tremor and rash.

Studies also suggested that weight gain, a concern with many anti-psychotic drugs used in adults, may occur with children treated with Risperdal, said Dr. Thomas Laughren, director of the FDA's psychiatry drugs division.

"These drugs do have some significant side effects, but they're quite predictable," Laughren told reporters.

Schizophrenia and bipolar disorders are serious conditions, and doctors and families should weigh the risks and benefits of drug treatment, he added.